Report of a pilot, double-blind, placebo-controlled study of megestrol acetate in elderly dialysis patients with cachexia

J Ren Nutr. 2010 Jan;20(1):52-62. doi: 10.1053/j.jrn.2009.08.005. Epub 2009 Oct 12.


Objective: We examined the effects of megestrol acetate versus placebo and progressive resistance physical exercise on weight, lean muscle mass, quality of life, ability to exercise, proinflammatory cytokines, and anti-inflammatory cytokines, and their correlations with one another.

Design: We organized a prospective 20-week, randomized, double-blind, placebo-controlled pilot trial of hemodialysis patients.

Setting: This study took place at the Outpatient Unit of the Northport Veteran Affairs Medical Center.

Subjects: We studied nine male hemodialysis patients who had two or more of the following: albumin level <4.0 g/dL, total cholesterol <150 mg/dL, protein catabolic rate <0.8 g/kg/day, and predialysis serum urea nitrogen <60 mg/dL. Their ages were 50 to 83 years. Two were diabetic, and seven were nondiabetic.

Interventions: Interventions included megestrol acetate (MA) or placebo 800 mg oral daily for 20 weeks, along with weight resistance physical therapy with weights twice a week before dialysis. Patients were followed prospectively for an additional 4 weeks.

Main outcome measurements: Weight, body composition, activities of daily living, ability to exercise, and plasma cytokine levels were measured.

Results: At 24 weeks, the MA group had a statistically significant weight gain (11.1-pound increase vs. 1.5-pound decrease for the placebo group, P = .018), body fat gain (6.2-pound increase vs. a 0.4-pound decrease for the placebo group, P = .044) and fat-free mass gain (5-pound increase vs. a 1.2-pound decrease in the placebo group). The MA group also had a greater tendency toward increased appetite and sense of well-being. The MA group showed a greater improvement in ability to exercise (mean change in rate of perceived exertion (RPE), 4.7) vs. the placebo group (mean change in RPE vs. 0.5, P = .02). Elevated cytokine levels were evident at baseline in both groups. In all patients, increases in weight, fat-free mass, sense of well-being, appetite, and ability to exercise were negatively correlated with tumor necrosis factor receptor subunit p75 (P < .05). There was a trend toward all of these parameters to be negatively correlated with tumor necrosis factor receptor subunit p55, although only sense of well-being was statistically significant (P < .05).

Conclusion: In a pilot trial in dialysis patients, MA showed significant benefits in improving weight and ability to exercise. Cytokine changes were correlated with weight gains and increases in fat-free mass.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Activities of Daily Living
  • Aged
  • Aged, 80 and over
  • Appetite Stimulants / administration & dosage*
  • Blood Urea Nitrogen
  • Body Composition
  • Body Weight
  • Cachexia / diagnosis
  • Cachexia / drug therapy*
  • Cachexia / therapy*
  • Cholesterol / blood
  • Cytokines / blood
  • Double-Blind Method
  • Exercise
  • Humans
  • Male
  • Megestrol Acetate / administration & dosage*
  • Middle Aged
  • Pilot Projects
  • Placebos
  • Prospective Studies
  • Protein Subunits / blood
  • Receptors, Tumor Necrosis Factor / blood
  • Renal Dialysis*
  • Resistance Training
  • Serum Albumin / analysis
  • Weight Gain


  • Appetite Stimulants
  • Cytokines
  • Placebos
  • Protein Subunits
  • Receptors, Tumor Necrosis Factor
  • Serum Albumin
  • Cholesterol
  • Megestrol Acetate